TULA

Primary DI
00840128600030
Brand
TULA
Company
Smith & Nephew, Inc.
Model
TULAKIT2L
Catalog number
TULAKIT2L
Device description
TULA KIT - BILATERAL - LONG EARSET
Published
2020-03-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QJATympanostomy tube delivery product with drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJATympanostomy Tube Delivery Product With DrugUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P190016000
P190016002

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P190016000Tula® SystemTusker Medical, Inc.2019-11-25QJA
P190016002Tula® SystemTusker Medical, Inc.2019-11-25QJA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840128600030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840128600030008401286000308401286000300840128600030

GMDN Terms#

Term, Definition table
TermDefinition
Drug-delivery iontophoresis system, single-useAn assembly of portable devices that may be used as an alternative to injections to transport ionic-solution medication through the movement of ions resulting from an applied electric field, to locally administer the medication transcutaneously. It typically consists of a disposable, battery-powered, current generator that supplies a constant direct current [e.g., 0.5 to 4 milliampere (mA)], a delivery electrode which typically contains a small reservoir of buffering agent and the medication (e.g., a corticosteroid or anaesthetic), a return electrode, and connecting lead wires. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00885556833940Salto Talaris Total Ankle ProsthesisMJU953TMJU953T2022-12-22
00885556833957Salto Talaris Total Ankle ProsthesisMJV219TMJV219T2022-12-22
00885556833964Salto Talaris Total Ankle ProsthesisMJV220TMJV220T2022-12-22
00885556833971Salto Talaris Total Ankle ProsthesisMJV221TMJV221T2022-12-22
00885556833988Salto Talaris Total Ankle ProsthesisMJV229TMJV229T2022-12-22
00885556834237Silicone Toe SystemCGT-205TCGT-205T2022-12-22
00885556834251Silicone Toe SystemCGT-305TCGT-305T2022-12-22
00885556834299Silicone Toe SystemCGT-505TCGT-505T2022-12-22
00885556835029Ti6 Internal Fixation SystemDS1007DS10072022-12-22
00885556835203Surgical InstrumentsFS-1006FS-10062022-12-22
00885556836187Ti6 Internal Fixation SystemTH3018TH30182022-12-22
00885556837856Total Foot System 2220425022042502022-12-22
00885556838785Total Foot System 2282302728230272022-12-21
00885556841631XT Revision Ankle Replacement SystemMJU984TMJU984T2022-12-21
00885556841778XT Revision Ankle Replacement SystemMJV222TMJV222T2022-12-21
00885556841785XT Revision Ankle Replacement SystemMJV223TMJV223T2022-12-21
00885556854921Freedom Wrist Arthroplasty System3480473480472022-12-22
00885556856680Surgical InstrumentsEXT-200-00EXT-200-002022-12-22
00885556860168Titan Modular Shoulder System 2.5DRL-0923-047-001DRL-0923-047-0012022-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556817667TULASmith & Nephew, Inc.QJA2024-04-29
00885556817674TULASmith & Nephew, Inc.QJA2024-04-23
00885556817742TULASmith & Nephew, Inc.QJA2024-04-23
00885556817759TULASmith & Nephew, Inc.QJA2024-04-23
00885556817766TULASmith & Nephew, Inc.QJA2024-04-23
00885556817773TULASmith & Nephew, Inc.QJA2024-04-23
00885556817780TULASmith & Nephew, Inc.QJA2024-04-23
00885556817797TULASmith & Nephew, Inc.QJA2024-04-23
20885556817685TULASmith & Nephew, Inc.QJA2024-04-23
20885556817692TULASmith & Nephew, Inc.QJA2024-04-23
20885556817708TULASmith & Nephew, Inc.QJA2024-04-23
20885556817715TULASmith & Nephew, Inc.QJA2024-04-23
20885556817722TULASmith & Nephew, Inc.QJA2024-04-23
20885556817739TULASmith & Nephew, Inc.QJA2024-04-23
00840128600160TULASmith & Nephew, Inc.QJA2020-03-27
00840128600054TULASmith & Nephew, Inc.QJA2020-03-25
00840128600078TULASmith & Nephew, Inc.QJA2020-03-25
00840128600085TULASmith & Nephew, Inc.QJA2020-03-25
00840128600092TULASmith & Nephew, Inc.QJA2020-03-25
00840128600108TULASmith & Nephew, Inc.QJA2020-03-25
00840128600115TULASmith & Nephew, Inc.QJA2020-03-25
00840128600122TULASmith & Nephew, Inc.QJA2020-03-25
00840128600207TULASmith & Nephew, Inc.QJA2020-03-25
00840128600016TULASmith & Nephew, Inc.QJA2020-03-25
00840128600023TULASmith & Nephew, Inc.QJA2020-03-25
00840128600047TULASmith & Nephew, Inc.QJA2020-03-25
20840128600058TULASmith & Nephew, Inc.QJA2020-03-25
20840128600072TULASmith & Nephew, Inc.QJA2020-03-25
20840128600089TULASmith & Nephew, Inc.QJA2020-03-25
20840128600096TULASmith & Nephew, Inc.QJA2020-03-25